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Keep this study
Lead
Chiesi Farmaceutici S.p.A.
A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD
Current smokers or ex-smokers
A post-bronchodilator FEV1 \< 60% of the predicted normal value and a post-bronchodilator FEV1/FVC \< 0.7
Positive response to the reversibility test at screening defined as change in FEV1 ≥ 5%.
BDI score ≤ 10
Patients free of exacerbations for at least 1 month
You may not be if
Pregnant or lactating women
Diagnosis of asthma
Patients treated for exacerbations in the 4 weeks prior to screening visit
Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
Known respiratory disorders other than COPD
Patients who have clinically significant cardiovascular condition
Clareo Health | Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
